The Analysis of Residual Solvents in Pharmaceuticals using Headspace GC

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The Analysis of Residual Solvents in Pharmaceuticals using Headspace GC

This white paper provides an overview on how the regulations have evolved through the pharmacopeias, how the ICH has impacted these regulations, how these could be implemented by manufacturers and the role of CROs in this process.

Pharmaceutical products come in to contact with residual solvents throughout their manufacturing and production processes. They are classified depending on their risk to human health and therefore the analysis of residual solvents is an important pharmacopeia testing requirement that regulatory organisations, for example the US Food and Drug administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), regard as highly important.

The following white paper will provide an overview of residual solvent testing as per the United States (US) Pharmacopeia and the testing carried out at Reading Scientific Services Ltd (RSSL).

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